150 mg, 200 mg, and 400 mg prolonged-release tablets are
carbamazepine
What Trimonil retard is and what it is used for
Trimoniwl retard prevents signals that trigger an epileptic seizure from spreading in the brain and therefore makes the onset of seizures more difficult. This also applies to alcohol withdrawal in cases where there is a risk of an epileptic seizure. The pain-relieving effect of Trimonil retard is probably due to a dampening effect on the nerves in the brain involved in the transmission of pain from the trigeminal nerve in the face.
Trimonil retard is used for epilepsy and certain forms of facial pain ( trigeminal neuralgia ), as well as for alcohol withdrawal.
The carbamazepine contained in Trimonil retard may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Trimonil retard
Do not take Trimonil retard
- if you are allergic to oxcarbazepine or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to closely related medicines (e.g. medicines for depression and moodiness)
- if you have or have previously had an unusual condition with disturbed metabolism of red blood cell pigments (e.g. acute intermittent porphyria, porphyria variegata, porphyria cutanea tarda)
- if you have a heart condition (AV block)
- if you have or have had certain diseases that cause low blood values (due to the influence of the bone marrow )
- if you are taking MAO inhibitors (for the treatment of depression or Parkinson’s disease ) or have taken such medicine in the last 14 days
Warnings and precautions
Talk to your doctor before taking Trimonil retard.
- if given to children under 6 years of age
- if you have a heart or vascular disease
- if you have kidney or liver disease
- if you are older than 65 years
- if you suffer from increased pressure in the eye ( glaucoma ) or urinary retention
- if you suffer from a degenerative muscle disease (myotonic dystrophy), as cardiac side effects are more common then
- if you suffer from sodium metabolism disorders
- if you have or have had blood disorders or reactions in the blood when taking other medicines
- if you show or have shown signs of an unusual hypersensitivity (e.g. skin rash) to other medicines used to treat epilepsy, such as oxcarbazepine, phenobarbital, phenytoin, or lamotrigine then you are also at a higher risk of developing an unusual hypersensitivity to carbamazepine. If you are/were allergic to carbamazepine, the probability of reacting allergically to oxcarbazepine is 25-30%.
- if you are a woman and can become pregnant. There is a risk of harm to the unborn child if Trimonil retard is used during pregnancy. Women of childbearing potential should use effective contraception during treatment with Trimonil retard and for two weeks after the last dose (see section Pregnancy and breast-feeding)
- if you take hormonal contraceptives, e.g. birth control pills, Trimonil retard can cause your contraceptive to not work. Use another or a complementary (non-hormonal) method of contraception while taking Trimonil retard to prevent unwanted pregnancy. Contact your doctor immediately if you experience irregular bleeding or breakthrough bleeding. Ask your doctor or another healthcare professional if you have any questions about this.
- if you experience dizziness, drowsiness, reduced blood pressure, or confusion due to treatment with Trimonil retard it may lead to you falling.
In rare cases, Trimonil retard can affect the white blood cells so that the defense against infection deteriorates or cause liver damage. Contact your doctor immediately if you develop symptoms such as fever, sore throat, skin rash with swollen lymph nodes and/or flu-like symptoms, small blood spots on the skin, easy bruising, or signs of liver inflammation such as tiredness, loss of appetite, nausea or yellowing of the skin and eyes during treatment with Trimonil retard.
Skin reactions, which can be life-threatening ( Stevens-Johnson syndrome and toxic epidermal necrolysis ) or hypersensitivity reactions (eg DRES’s syndrome with rash, swollen lymph nodes, fever, and possible involvement of other organs), have been reported when using Trimonil retard. It may begin as red-violet target-like or round spots with central blistering, often symmetrically distributed, on the trunk. Additional signs to watch out for are sores in the mouth, throat, nose, genitals, or eye inflammation (red and swollen eyes).
The skin reactions, which can be life-threatening, are often followed by flu-like symptoms. The rash can develop into blisters over large areas or skin peeling.
The risk of serious skin reactions is greatest during the first weeks of treatment.
If you have suffered from Stevens-Johnson syndrome or toxic epidermal necrolysis when using Trimonil retard, you must never use Trimonil retard again.
If you develop a rash or signs of these skin reactions, stop taking Trimonil retard immediately, and contact your doctor immediately and tell them that you are taking this medicine.
These serious skin reactions may be more common in people from certain Asian countries. The risk of these side effects in patients of Han Chinese or Thai origin can be determined by a blood test. Doctors should be able to tell you if a blood test is necessary before you start taking carbamazepine.
A small number of people treated with anti-epileptic drugs such as carbamazepine have also had thoughts of harming themselves or committing suicide. If you ever have these thoughts, contact your doctor immediately.
Natural remedies containing St. John’s wort (Hypericum perforatum) should not be used during medication with Trimonil retard.
You should protect yourself from strong sunlight, as you are more susceptible to skin damage from the sun during treatment with Trimonil retard.
Treatment with Trimonil retard requires regular monitoring by your doctor about blood, liver, and kidney function. If you are a glaucoma patient, the pressure in your eye should also be checked regularly. You must participate in these checks.
If you are treated with thyroid hormone, your doctor will want to check your thyroid function at the beginning and after finishing treatment with Trimonil retard and adjust the dose of thyroid hormone if necessary.
Since Trimonil retard can cause dry mouth, careful oral hygiene should be observed (tooth brushing with fluoride toothpaste twice daily).
Other medicines and Trimonil retard
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are using antidepressants from the group of monoamine oxidase inhibitors ( MAO inhibitors ), that treatment must have ended at least 14 days before you can start taking Trimonil retard.
The treatment effect can be affected if you take Trimonil retard together with other medicines. Treating physicians must therefore be aware of all other medications. This applies to both prescription and non-prescription drugs.
Certain pain medicines ( dextropropoxyphene ), depression (nefazodone), anesthesia (midazolam), and natural medicines containing St. John’s wort (Hypericum perforatum) should be avoided in connection with Trimonil retard treatment. If you are already taking a St. John’s wort preparation, you should contact your doctor before you stop taking this natural medicine.
Other medicines can increase or decrease the level of carbamazepine in the blood. Increased levels of carbamazepine in the blood can cause side effects (eg dizziness, sleepiness, problems coordinating movements, double vision). Decreased levels of carbamazepine in the blood may cause a worsening of your illness, e.g. recurrent epileptic seizures or feeling pain in the face, mouth, or throat.
Hormonal contraceptives (e.g. birth control pills, patches, injections, or implants ): Trimonil retardcan affect how hormonal contraceptives work and make them less effective at preventing pregnancy. Talk to your doctor to choose together the type of contraceptive that is most suitable when you take Trimonil retard.
In addition, the effect of other drugs can be affected by Trimonil retard. Therefore, always tell the doctor who prescribes another medicine for you that you are using Trimonil retard.
Therefore, consult your doctor before using other medicines at the same time. This applies in particular to the following medicines:
- certain drugs for cardiovascular diseases (felodipine, nimodipine, verapamil, diltiazem, simvastatin, atorvastatin, lovastatin, ivabradine, antiarrhythmic agents such as digoxin, quinidine )
- certain medicines for diabetes (pioglitazone, troglitazone)
- during sex hormone treatment (hormonal contraceptives such as birth control pills, estrogens, progesterone derivatives, danazol)
- during hormone therapy (thyroid hormones, corticosteroids, e.g. prednisolone, dexamethasone)
- for certain anti-infective agents ( isoniazid, doxycycline, macrolide antibiotics such as erythromycin, troleandomycin, josamycin, clarithromycin, ciprofloxacin)
- for pain (buprenorphine, fentanyl, methadone, tramadol, dextropropoxyphene, ibuprofen, phenazone, paracetamol )
- against epilepsy (brivaracetam, eslicarbazepine, ethosuximide, felbamate, phenobarbital, phenytoin , fosphenytoin, clobazam, clonazepam, lamotrigine, levetiracetam, oxcarbazepine, primidone, progabid, stiripentol, tiagabine, topiramate, valoctamide, valproic acid , valpromide, vigabatrin, zonisamide)
- against depression/depression (amitriptyline, desipramine, imipramine, fluoxetine, fluvoxamine, citalopram, sertraline, clomipramine, mianserin, mirtazapine, nefazodone, nortriptyline, bupropion, trazodone, viloxazine, paroxetine )
- for anxiety (alprazolam, midazolam)
- against vomiting and nausea (ondansetron, aprepitant, metoclopramide)
- blood thinners (such as dicoumarol, warfarin, acenocoumarol, ticlopidine, rivaroxaban, dabigatran, apixaban, and edoxaban)
- certain agents that inhibit the immune system (ciclosporin, everolimus, tacrolimus, sirolimus)
- certain muscle relaxants (pancurone, dantrolene, oxybutynin)
- certain drugs against viral diseases (efavirenz, nevirapine, so-called protease inhibitors such as indinavir, saquinavir, or ritonavir)
- medicine used to treat hepatitis C infection: sofosbuvir
- certain antipsychotics ( haloperidol, bromperidol, clozapine, olanzapine, lithium, risperidone, loxapine, quetiapine, aripiprazole, thioridazine, ziprasidone, paliperidone)
- against fungal infections ( fluconazole , itraconazole, ketoconazole , voriconazole)
- certain medicines against worm infections (praziquantel, albendazole)
- for asthma or allergy ( loratadine, theophylline, aminophylline, terfenadine, fexofenadine)
- certain diuretics (acetazolamide, furosemide , hydrochlorothiazide)
- remedies for stomach ulcers and heartburn (cimetidine, omeprazole)
- certain medicines used in cancer treatment (imatinib, lapatinib, doxorubicin, cyclophosphamide, temsirolimus)
- means for the treatment of tuberculosis (rifampicin, rifabutin) and nicotinamide ( vitamin B )
- methylphenidate (a central stimulant mainly used in ADHD )
- tadalafil (used for erectile dysfunction )
- agent for the treatment of breast cancer (toremifene)
Trimonil retard with food, drink, and alcohol
Do not drink grapefruit juice while taking Trimonil retard, as the level of carbamazepine in the blood may increase, leading to an increased risk of side effects.
You may be more affected by alcohol than usual. You should therefore not drink alcohol during treatment with Trimonil retard.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Pregnancy
Trimonil retard can cause serious malformations. If you take Trimonil retard during pregnancy, your child is up to 3 times more likely to have a malformation than children of women who do not take any medicine against epilepsy. Severe malformations have been reported, such as neural tube defects (opening in the spine), malformations of the face (eg, cleft lip and palate ), skull, heart, penis, urinary opening (hypospadias), and fingers. Your unborn child should be closely monitored if you have taken Trimonil retard during pregnancy.
Problems with the child’s neurological development (development of the brain) have been reported in children of women who have used Trimonil retard during pregnancy. Some studies have shown that carbamazepine negatively affects the neurological development of children exposed to carbamazepine during pregnancy, while other studies have found no such effect. It cannot be ruled out that carbamazepine can affect the child’s neurological development.
If you are a fertile woman and do not plan to become pregnant, you must use effective contraception during treatment with Trimonil retard. Trimonil retard can affect how hormonal contraceptives, e.g. birth control pills, work and make them less effective in preventing pregnancy. Talk to your doctor, who will discuss with you what type of contraception is most appropriate to use while you are taking Trimonil retard. If treatment with Trimonil retard is stopped, you must continue to use effective contraception for another two weeks after stopping treatment.
If you are a fertile woman and planning to become pregnant, you should – before stopping contraception and before becoming pregnant – talk to your doctor about changing to other suitable treatments. This is to avoid exposing the unborn child to carbamazepine.
If you are pregnant or think you may be pregnant, tell your doctor immediately. Do not stop taking the medicine until you have discussed this with the doctor. If you stop taking the medicine without consulting the doctor, it can cause epileptic seizures which can be dangerous for you and your unborn baby. The doctor may decide that the treatment should be changed.
Folic acid deficiency can be caused by Trimonil retard and contribute to the development of malformations. Therefore, intake of folic acid is recommended before and during pregnancy. If you take Trimonil retard during pregnancy, your baby is also at risk of bleeding problems immediately after birth. Your doctor can give you and your child medicine to prevent this.
Breast-feeding
The active substance carbamazepine passes into breast milk in only small amounts. It is therefore usually possible to breastfeed the child during the treatment. However, if your child shows poor weight gain or is abnormally sleepy, or suffers from other side effects such as diarrhea, vomiting, skin rash, or yellowing of the skin and eyes, breastfeeding should be discontinued. In any case, consult your doctor if you use Trimonil retard while breastfeeding.
Fertility in men
Very rare cases of reduced male fertility (low sperm count and/or low sperm motility) have been reported.
Driving ability and use of machinery
Trimonil retard can make you feel sleepy or dizzy. You may also experience blurred vision, double vision, or difficulty coordinating muscle movements, especially at the beginning of your treatment or after a dose increase. This may affect your ability to drive, use machinery or perform other activities that require increased vigilance.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Trimonil retard contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to take Trimonil retard
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The dose must be determined by the doctor, who adjusts it individually for the patient. The usual dose for adults is 800 – 1200 mg per day for epilepsy treatment and 600 – 800 mg per day for the other indications divided into 2 dosing occasions.
The usual dose for children is 10 – 20 mg per kg of body weight per day divided into 2 dosing occasions. In children under 6 years of age and especially when increasing the dose, rapid-release pharmaceutical forms are recommended instead of prolonged-release tablets.
Instructions for use
Trimonil retard prolonged-release tablets can be split but must not be crushed. Swallow the tablets whole with a small amount of liquid either with a meal or between meals. Carefully follow the doctor’s prescription. This is especially important in epilepsy to get adequate seizure protection.
If you have taken too much Trimonil retard
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Trimonil retard
If you forget to take a dose, take it as soon as you remember and then continue as usual. Do not take a double dose to make up for the missed dose. If you forget several doses, contact your doctor.
If you stop taking Trimonil retard
When Trimonil retard is used against epilepsy, you should not suddenly stop the treatment. Never change the dose or stop using your medication without first consulting your doctor, as this may worsen your illness.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects occur more often with combination therapy and usually occur at the beginning of treatment.
Some side effects can be serious. Seek immediate medical attention if you experience any of the following:
Agranulocytosis (rare side effect ):
In rare cases, Trimonil retard can affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with a greatly worsened general condition or fever with local symptoms of infection such as sore throat/pharynx/mouth or difficulty urinating, you should see a doctor as soon as possible so that a lack of white blood cells can be ruled out via a blood test ( agranulocytosis ). It is important that you then information about your medication.
Severe allergic reactions ( anaphylaxis ) (very rare side effect )
Sudden itching, rash, difficulty breathing up to shock.
Angioedema (very rare side effect ):
Stop taking Trimonil retard and contact a doctor immediately if you develop swelling of the face, tongue, or throat; difficulty swallowing; hives, and difficulty breathing.
Hypersensitivity reaction (rare side effect ) :
Hypersensitivity reactions with fever, skin rash, inflammation of the blood vessels, changes in the lymph nodes, joint pain, and altered blood levels can occur in various combinations and can affect other organs (e.g. liver, lungs, kidneys, pancreas, heart muscle, large intestine).
Toxic epidermal necrolysis (rare side effect ):
Severe widespread skin damage (skin peeling of the epidermis and superficial mucous membranes) see section 2.
Stevens-Johnson syndrome (rare side effect ):
An extremely strong allergic reaction with a skin rash is usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as the genitals, see section 2.
DRES’s syndrome (frequency not known)
A syndrome consisting of skin rash, enlarged lymph nodes, fever, and possibly affecting other organs.
Liver disease (rare to very rare side effect ):
Contact your doctor immediately if you develop signs of liver disease such as dullness, loss of appetite, nausea, or yellow-colored skin during treatment with Trimonil retard.
Decrease in the number of platelets or blood cells (common to very rare side effect ):
Showing signs such as tiredness, shortness of breath with light exertion, paleness, headache, chills, dizziness, repeated infections with fever, sore throat, mouth sores, bleeding or bruising that occurs more easily than usual, nosebleeds, reddish or purple-red marks on the skin or unexplained patchy skin rash.
Systemic lupus erythematosus ( SLE ) or SLE – like disease (rare side effect ):
A disorder of the immune system that causes symptoms such as joint pain, rash, fatigue, fever, nausea, or loss of appetite.
Porphyria disease (rare side effect ):
This leads to increased excretion of blood dyes in the urine which becomes dark or reddish.
Effect on kidney function (rare side effect ):
Decreased or increased amount of urine, blood, or protein in the urine.
Pancreatitis (very rare side effect ):
Severe pain in the upper stomach area, vomiting, loss of appetite
Low amount of sodium in the blood (common side effect ):
Shows signs such as swelling of the hands, feet, and legs or weight gain, rarely accompanied by lethargy, vomiting, headache, confusion, and other mental illnesses.
Meningitis is not caused by bacteria (aseptic meningitis ) (rare side effect ):
Exhibits signs such as fever, nausea, vomiting, headache, stiff neck, extreme sensitivity to bright light, and muscle twitching.
Neuroleptic malignant syndrome (very rare side effect ):
Severe reaction with sudden fever, very high blood pressure, severe convulsions, muscle stiffness, or mental confusion.
Cardiac disorders and disorders of the circulatory system (uncommon to rare side effects ):
For example. heart failure, slow or irregular heartbeat possibly with fainting, impaired oxygenation of the coronary arteries of the heart leading to chest pain, and circulatory collapse.
Cases (have been reported) (frequency not known):
If you fall due to dizziness, drowsiness, decreased blood pressure, or confusion.
The following side effects can also occur when using Trimonil retard:
Very common side effects: may affect more than 1 in 10 users
- increased need for sleep, sleepiness, exhaustion
- increase of a certain liver enzyme (gamma-GT)
Common side effects: may affect up to 1 in 10 users
- dizziness
- increase in certain types of white blood cells (eosinophilic)
- fatigue, sleepiness
- balance disorders
- loss of appetite
- nausea, vomiting, diarrhea, constipation,
- skin rash with or without fever and hives, possibly serious (see above “Some side effects can be serious”)
- visual disturbances (e.g. blurred vision), double vision
- dry mouth (careful oral hygiene is therefore important)
- increased levels of certain enzymes found in the liver or bones (alkaline phosphatase) and certain liver enzymes ( transaminases )
Uncommon side effects: may affect up to 1 in 100 users
- headache
- increased number of white blood cells
- involuntary movements (such as shaking, tremors, twitching, jerky movements)
- involuntary eye movements ( nystagmus )
- increased levels of urea in the blood (azotemia)
Rare side effects: may affect up to 1 in 1,000 users
- blood clots, inflammation of the blood vessels
- too high or too low blood pressure
- dyskinetic disorders such as involuntary movements in the jaw area (orofacial dyskinesia ), excessive and uncontrollable movements (choreoathetosis)
- difficulty speaking (slurred or poorly articulate speech)
- nerve inflammation in the arms and legs, impaired nerve function with symptoms such as pain, burning sensation, tingling, itching or tingling, sensory disturbances ( paresthesia, polyneuropathy, peripheral neuropathy ), paralysis (paresis)
- movement disorders in the eye
- enlargement of the mammary glands in men ( gynecomastia ), milk flow from the breasts even without breastfeeding ( galactorrhea )
- taste disturbance
- inflammation of the tongue or mouth ( glossitis, stomatitis )
- abdominal pain
- severe allergic skin reactions (e.g. erythema multiforme, erythema nodosum, exfoliative dermatitis, erythroderma see also above “Some side effects can be serious”)
- hair loss increased facial hair growth (in women)
- changed skin pigmentation, itching, acne, small bleeding in the skin, sweating
- sunlight hypersensitivity
- allergic lung problems with symptoms such as fever, breathing difficulties, and infection in the respiratory tract ( pneumonitis, pneumonia )
- laboratory picture as in case of lowered thyroid function, increased fat content in the blood
- muscle pain, joint pain, muscle cramps, muscle weakness
- confusion, agitation, and restlessness, especially in elderly patients, activation of other psychotic symptoms, depression or manic moods
- visual or auditory hallucinations, anxiety, aggressiveness, depression, anorexia
- difficulty passing water (urinating), frequent urination in small amounts
- sexual disorders
- lens clouding, eye inflammation
- tinnitus, increased sensitivity to sound
- reduced levels of vitamin D, which can lead to softening of the skeleton
- fever
- swollen lymph nodes
- reduced levels of folic acid
Very rare side effects: may affect up to 1 in 10,000 users
- inflammation of blood vessels
- hearing damage such as impaired hearing or changes in pitch perception
- enlarged spleen
- inflammation of the gums ( gingivitis )
- urination problems such as frequent or painful urination
- sexual disorders such as impotence and decreased sexual desire (libido)
- reduced male fertility (low sperm count and/or low sperm motility)
- impaired thought processes, lack of energy
- increased levels of a hormone involved in regulating lactation ( prolactin )
- increased levels of a certain hormone ( cortisol )
Not known frequency: occurs in an unknown number of users
- allergic cross-reactions with other antiepileptic drugs
- increased pressure in the eye, damage to the eye (genotoxicity)
- scarring of the lungs ( pulmonary fibrosis )
- patchy loss of pigment cells in the skin (vitiligo)
- loss of nails (onychomadesis)
- benign papules or plaques on the skin (lichenoid keratosis )
- decreased vitamin B 12 levels and increased homocysteine levels in the blood
- high levels of ammonia in the blood (hyperammonemia). Symptoms of hyperammonemia may include irritability, confusion, vomiting, loss of appetite, and sleepiness.
- worsening of multiple sclerosis symptoms
- low levels of antibodies in the blood ( hypogammaglobulinemia )
- bone marrow damage
- colon inflammation ( colitis )
- reactivation of infection with human herpesvirus 6
- memory impairment
There have been reports of bone diseases, e.g. reduced bone density in the skeleton, osteoporosis, and bone fractures. Contact a doctor or pharmacist if you are being treated with epilepsy medication for a long time, if you know you have osteoporosis or if you are taking steroids.
As with other anti-epileptic drugs, Trimonil retard in some patients can lead to an increase in the frequency of seizures, especially absence seizures (seizures with short-term loss of consciousness) can worsen.
How Trimonil retard should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging after the Issue. dat. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is carbamazepine. 1 prolonged-release tablet contains 150 mg, 200 mg, and 400 mg carbamazepine respectively.
Other ingredients are microcrystalline cellulose, magnesium stearate, methacrylic acid copolymer, sodium starch glycolate, colloidal silicon dioxide, talc
Appearance and package sizes of the medicine
Trimonil retard 150 mg, Trimonil retard 200 mg, Trimonil retard 400 mg:
50, 100, or 200 prolonged-release tablets (blisters)
Also applicable to Trimonil retard 200 mg and Trimonil retard 400 mg:
100 or 200 prolonged-release tablets (plastic container)
Not all pack sizes may be marketed.
DESITIN ARZNEIMITTEL GMBH
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D-22335 Hamburg
Germany
Information providing company
Desitin Pharma AB
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Norway